Rottendorf Pharma GmbH
About Rottendorf Pharma GmbH
Certifications
-
FDA -
GMP
Categories
-
Country/Region:Germany
-
Founded:1928
-
On CPHI since:2015
-
Certificates:3
-
Employees:1000 - 4999
Company types
Primary activities
Contact info
-
-
-
Ostenfelder Str. 51-61, 59320, Ennigerloh, Germany
Meet us at
CPHI Americas 2026
Pennsylvania Convention Center, Philadelphia
2 Jun 2026 - 4 June 2026
CPHI Milan 2026
Fiera Milano, Italy
6 Oct 2026 - 8 Oct 2026
Products from Rottendorf Pharma GmbH (18)
-
Product Analytics
Comprehensive analytical services from method development and transfer to routine testing of raw materials, excipients and finished products in a GMP/FDA-certified laboratory, leveraging over 180 experts and advanced techniques (HPLC, GC, dissolution, Karl Fischer, ICP, TLC, etc.) to ensure regulatory comp... -
Product Blending
Robust mixing of APIs and excipients using high-shear blenders (Diosna P600, VAC 10+60) and free-fall blenders (Bohle PM-series) in both development (0.5–150 kg) and commercial manufacturing (2–750 kg) to achieve uniform blend homogeneity. -
Product Blister Packaging
High-speed blister packaging on 13 fully automated lines (Uhlmann BEC 300/500, IMA Giant), handling PVC/PVDC, Alu-Alu, ACLAR® and PP foils with serialization and aggregation capabilities in a GMP certified cleanroom environment. -
Product Bottle packaging
Automated bottle filling on three Uhlmann IBC 120/150 lines and one powder-filling line (Optima), including counting, induction sealing, torque-controlled capping and 100 % in-line inspection, all under GMP compliance. -
Product Clinical trial manufacturing
GMP-compliant production of Phase I–III clinical samples (0.5–150 kg) in an FDA-approved pilot plant, with dedicated project teams for formulation, process upscaling and analytical method support. -
Product Film Coating
Tablet film coating on seven dedicated coaters (All scales available: Bohle BFC 5, BFC50, BFC400, BFC600) for aqueous and organic solvent processes, with automated parameter control and full process documentation in a GMP-certified environment. -
Product Formulation development
Formulation and process development for oral solid dosage forms from lab and pilot scale to commercial production (0.5–150 kg) in a GMP/FDA-approved pilot plant; includes dry-, fluid-bed- and wet granulation, hot-melt extrusion/melt granulation, tabletting, filmcoating, mini-tablet and pellet technologies;... -
Product Granulate Filling
Precision filling of dry granulates into bottles using gravimetric and volumetric dosing, integrated bottle cleaning, camera inspection, induction sealing and torque-controlled capping, ensuring uniform fill weights under cleanroom and GMP conditions. -
Product Granulation
End-to-end granulation services including fluid-bed (GPCG series), high-shear (Diosna series) and dry roller compaction (Gerteis Mini- and Macropactor) for batch sizes from 1 to approx. 750 kg, all conforming to GMP requirements. -
Product High-Potency Products
Handling of high-potency APIs with an OEL values from 1µg/m³ onwards is dpendent on drug load and manufcaturing process. Rottendorf will invest into high potency for handling compounds with an OEL value of 0.1/m³. -
Product Hot Melt Extrusion
Continuous melt extrusion using co-rotating twin-screw extruders (Leistritz ZSE 18HP) enabling enhanced solubility and controlled-release pellet formation. -
Product Hot Melt Granulation
Solvent-free hot melt granulation with heated hoses and nitrogen circulation to improve bioavailability of poorly soluble APIs.
Rottendorf Pharma GmbH Resources (1)
-
News Rottendorf Pharma and Corealis Pharma Offer Seamless OSD Development and Manufacturing
Faster time to market: Integrated early-development offering and accelerated commercial pathway for biotech companies.